sutter sync

GUDID 26945630136669

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, reusable
Primary Device ID26945630136669
NIH Device Record Key0ed99fc3-d8a4-4c3b-bb98-d5a382c36ba0
Commercial Distribution StatusIn Commercial Distribution
Brand Namesutter sync
Version Model NumberLDE4
Company DUNS554434897
Company NameSterilance Medical (Suzhou) Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106945630136665 [Primary]
GS126945630136669 [Package]
Contains: 06945630136665
Package: [50 Units]
In Commercial Distribution
GS136945630136666 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Product Code

QRLMultiple Use Blood Lancet For Single Patient Use Only

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-02
Device Publish Date2025-05-23

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

26945630136669 - sutter sync2025-06-02
26945630136669 - sutter sync2025-06-02
36945630136673 - suttersync2025-06-02
36945630136178 - TRANSTEK2025-04-30
36945630136147 - TRANSTEK2025-04-30
36945630136154 - TRANSTEK2025-04-30
26945630136164 - TRANSTEK2025-04-30
36945630135805 - Bard2025-03-31
06945630135316 - STERiLANCE OneStep Lancing Device2025-03-20

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.